Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

NCT03128411

Last updated date
Study Location
Fujita Health University Hospital
Toyoake-City, Aichi, 470-1192, Japan
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Leukemia, Chronic Myelogenous
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of CP CML of ≤6 months (from initial diagnosis); Diagnosis of CP CML with molecular confirmation by detection of BCR-ABL rearrangement at screening (cytogenetic assessment for Ph is not required for enrollment; however, patients with known Ph- CML prior to registration are not eligible for this study)

- Age ≥20 years

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

- Adequate Liver and Renal Function

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Any prior medical treatment for CML, including TKIs, with the exception of hydroxyurea
treatment, which is permitted for up to 6 months prior to registration


- Any past or current CNS involvement, including leptomeningeal leukemia


- Extramedullary disease only


- Major surgery or radiotherapy within 14 days prior to registration


- History of clinically significant or uncontrolled cardiac disease


- Patients with active, uncontrolled bacterial, fungal, or viral infection


- Recent or ongoing clinically significant GI disorder


- History of another malignancy within 5 years prior to registration


- Uncontrolled hypomagnesemia or uncorrected hypokalemia due to potential effects on the
QT interval


- Known prior or suspected severe hypersensitivity to study drugs or any component in
their formulations


- Participation in other studies involving investigational drug(s) within 30 days or 5
half-lives of investigational product, whichever is longer, prior to registration
and/or during study participation


- Other severe acute or chronic medical or psychiatric condition, including recent or
active suicidal ideation or behavior, or laboratory abnormality that may increase the
risk associated with study participation or interfere with the interpretation of study
results


- Investigational site staff members directly involved in the conduct of the study and
their family members, or Pfizer employees, including their family members, directly
involved in the conduct of the study

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Leukemia, Chronic MyelogenousStudy of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia NCT03128411
  1. Toyoake-City, Aichi
  2. Toyohashi, Aichi
  3. Akita City, Akita
  4. Narita, Chiba
  5. Toon-shi, Ehime
  6. Kobe-city, Hyogo
  7. Kanazawa, Ishikawa
  8. Yokohama, Kanagawa
  9. Kawachinagano, Osaka
  10. Osaka-City, Osaka
  11. Osaka-Sayama, Osaka
  12. Hamamatsu-shi, Shizuoka
  13. Bunkyo-ku, Tokyo
  14. Bunkyo-ku, Tokyo
  15. Bunkyo-ku, Tokyo
  16. Shinagawa-ku, Tokyo
  17. Tachikawa, Tokyo
  18. Yamagata-Shi, Yamagata
  19. Chiba,
  20. Fukuoka,
  21. Saga,
ALL GENDERS
20 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study of Bosutinib in Japanese Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Official Title  ICMJE A PHASE 2, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE EFFICACY AND SAFETY OF BOSUTINIB MONOTHERAPY IN JAPANESE ADULT PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOGENOUS LEUKEMIA
Brief Summary Phase 2, single-arm, open-label trial. Patients will receive bosutinib for the duration of the study.
Detailed Description The study will be open for enrollment until the planned number of approximately 60 Philadelphia Chromosome Positive (Ph+) patients have been registered. All patients will be treated and/or followed for up to approximately 3 years (144 weeks) after registration of the last patient or until study termination. Patients who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to approximately 3 years (144 weeks) after registration of the last patient or until study termination.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Leukemia, Chronic Myelogenous
Intervention  ICMJE Drug: Bosutinib
All patinets will receive bosutinib at a starting dose of 400 mg QD.
Study Arms  ICMJE Experimental: Bosutinib
Bosutinib monotherapy; All patients will receive bosutinib at a starting dose of 400 mg QD. The dose of bosutinib may be escalated (up to a maximum of 600 mg QD) for unsatisfactory response or reduced for toxicity.
Intervention: Drug: Bosutinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 20, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2020
Actual Primary Completion Date March 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of CP CML of ?6 months (from initial diagnosis); Diagnosis of CP CML with molecular confirmation by detection of BCR-ABL rearrangement at screening (cytogenetic assessment for Ph is not required for enrollment; however, patients with known Ph- CML prior to registration are not eligible for this study)
  • Age ?20 years
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • Adequate Liver and Renal Function

Exclusion Criteria:

  • Any prior medical treatment for CML, including TKIs, with the exception of hydroxyurea treatment, which is permitted for up to 6 months prior to registration
  • Any past or current CNS involvement, including leptomeningeal leukemia
  • Extramedullary disease only
  • Major surgery or radiotherapy within 14 days prior to registration
  • History of clinically significant or uncontrolled cardiac disease
  • Patients with active, uncontrolled bacterial, fungal, or viral infection
  • Recent or ongoing clinically significant GI disorder
  • History of another malignancy within 5 years prior to registration
  • Uncontrolled hypomagnesemia or uncorrected hypokalemia due to potential effects on the QT interval
  • Known prior or suspected severe hypersensitivity to study drugs or any component in their formulations
  • Participation in other studies involving investigational drug(s) within 30 days or 5 half-lives of investigational product, whichever is longer, prior to registration and/or during study participation
  • Other severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or interfere with the interpretation of study results
  • Investigational site staff members directly involved in the conduct of the study and their family members, or Pfizer employees, including their family members, directly involved in the conduct of the study
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03128411
Other Study ID Numbers  ICMJE B1871048
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP